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New treatment option for Antibody-Mediated Rejection
Official title Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
ClinicalTrials.gov ID: NCT06744647
What this study is testing
What is ALXN2030?
ALXN2030 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for antibody-mediated rejection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Kidney transplant received ≥ 6 months
- Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
- Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II...
- MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
- eGFR ≥ 30 mL/min/1.73 m2
You likely can't join if
- Biopsy-based diagnosis of any of the following at Screening:
- TCMR, according to the Banff grade ≥ 1
- Polyoma virus nephropathy
- Severe thrombotic microangiopathy
- Glomerulonephritis
- ABO-incompatible transplant
See the full eligibility criteria
- Kidney transplant received ≥ 6 months
- Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
- Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity...
- MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
- eGFR ≥ 30 mL/min/1.73 m2
- Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1
- Must be vaccinated for S pneumoniae prior to randomization
- Must be vaccinated for H influenzae type B (where available) prior to randomization
- Body weight ≥ 50 kg at Screening
- Biopsy-based diagnosis of any of the following at Screening:
- TCMR, according to the Banff grade ≥ 1
- Polyoma virus nephropathy
- Severe thrombotic microangiopathy
- Glomerulonephritis
- ABO-incompatible transplant
- uACR \> 2200 mg/g
- Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
- Planned or recent treatments, \< 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome...
- Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Livingston, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.